Skip to main content
OpenTrials
Completed

NCT Number: NCT02012361

Inspired Helium for Ischemic Protection During Knee Replacement Surgery

The purpose of this study is to determine whether breathing in helium reduces indications of injury to the skeletal muscle seen in blood tests after knee replacement surgery.

The ability to reduce the risk of skeletal muscle injury may help improve patient safety by providing protection to the area of the body having its blood supply interrupted during a particular surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UF Health

Gainesville, Florida, 32610, United States

About this study

During hospitalization, beginning the day after surgery, additional tests will be added to the daily standard of care blood samples. When daily blood samples are not ordered as part of a study participants care after surgery, blood samples only for the study tests, may be done.

Up to 60 study participants will be selected to be in one of two possible groups.

After hospital discharge the study participants physical therapist will be contacted for copies of the notes and reports about the participants progress in physical therapy. This information will be used to evaluate if the different breathing gases have any impact on how quickly people recover after surgery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for an elective total knee arthroplasty
  • > 18 years of age
  • Expected to require inhaled oxygen concentrations < 25%
  • Able to provide informed consent

Exclusion criteria

  • Expected to require inhaled oxygen concentrations > 25%
  • < 18 years of age
  • Member of a defined vulnerable population (e.g. pregnant, mentally handicapped, prisoners, etc.).

Treatment and study plan

Control Group

Procedure

This group will be treated as any other patient would. Their anesthesia will be conducted as per routine with a target FiO2 of 0.25, (25%oxygen / 75%nitrogen) the only exception being that they will not be treated with inspired heliox.

Single-Dose Heliox Group

Procedure

This group will be treated with a single dose of inspired 75/25 heliox (75% helium 25% oxygen) breathed continuously for 15 minutes over any convenient window prior to the inflation of the surgical tourniquet. This will be the only change in their clinical care. Their anesthesia will be conducted as per routine and as the anesthesia team sees fit with a target FiO2 of 0.25, the only exception being that they will receive 75/25 heliox prior to the inflation of the tourniquet.

Muscle biopsy

Procedure

During the course of the operation a small muscle biopsy will be collected.

Primary outcomes

  1. Expression of serum markers

    Time frame: up to 5 days

    Post-operative expression of serum markers of injury to the skeletal muscle after knee arthroplasty.

    The primary endpoint will be detection of a decrease in the peak increase of CK detectable in the blood. A 15% decrease will be considered clinically significant.

Secondary outcomes

  1. Recovery of quadriceps function

    Time frame: Up to one year

    Length of time of transition from a walker to a cane.

Other outcomes

  1. Post-surgical time course of potassium

    Time frame: up to 5 days

    Changes in the time course of the peak level of expression of potassium will be analyzed.

  2. Post-surgical time course of urea (BUN)

    Time frame: up to 5 days

    Changes in the time course of the peak level of expression of urea (BUN) will be analyzed.

  3. Post-surgical time course of lactic acid

    Time frame: up to 5 days

    Changes in the time course of the peak level of expression of lactic acid will be analyzed.

  4. Post-surgical time course of lactate dehydrogenase

    Time frame: up to 5 days

    Changes in the time course of the peak level of expression of lactate dehydrogenase will be analyzed..

  5. Post-surgical time course of aldolase

    Time frame: up to 5 days

    Changes in the time course of the peak level of expression of aldolase will be analyzed.

  6. Post-surgical time course of creatinine phosphokinase (CK)

    Time frame: up to 5 days

    Changes in the time course of the peak level of expression of creatinine phosphokinase (CK) will be analyzed.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 16, 2013
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.